Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

MK-0518 (Raltegravir)

Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.

Baseline Measures

MK-0518 (Raltegravir)

Overall Participants Analyzed [Units: Participants]

52

Age [Units: Years]Mean (Full Range)

53
(40 to 71)

Gender [Units: Participants]

Female

4

Male

48

Region of Enrollment [Units: Participants]

United States

52

Time of Prior Antiretroviral Therapy Use [Units: Years]Mean (Full Range)

15
(7 to 22)

Number of Past Antiretrovials Used [Units: Medications]Mean (Full Range)

15
(4 to 22)

Time on Enfuvirtide Therapy [1] [Units: Days]Mean (Full Range)

997
(264 to 2457)

[1]

mean length of time on enfuvirtide therapy before change to MK-0518 (raltegravir)

To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen.

Time Frame

24 Weeks

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Analysis used the intent to treat (ITT) population, defined as all patients who received at least one dose of raltegravir.

Reporting Groups

Description

MK-0518 (Raltegravir)

Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.

No statistical analysis provided for Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.

2. Secondary:

Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24 [ Time Frame: 24 Weeks ]

Measure Type

Secondary

Measure Title

Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24

Measure Description

To study the immunologic effect of changing enfuvirtide to MK-0518 (raltegravir) in HIV-1 infected patients who have an undetectable level of serum HIV (undetectable serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay)on their current HIV medication regimen.

Time Frame

24 Weeks

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Analysis was per intention to treat (ITT) population defined as all patients who received at least one dose of raltegravir.

Reporting Groups

Description

MK-0518 (Raltegravir)

Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

A limitation of our study was the lack of a separate control arm. However, patients did serve as their own control by virtue of at least 6 months of HIV-1 ribonucleic acid(RNA)levels below the level of quantification before enrollment in the study.